Catheter hub with detachable push device

ABSTRACT

A handle member for gripping a catheter shaft to facilitate advancement in a patient&#39;s body lumen. The handle member is configured to be releasably secured to the catheter shaft. Further, the handle is longitudinally displaceable along at least a length of the catheter shaft, so as to be slidably positional along the shaft. The handle member may be detachably connected to an adapter on the proximal end of the catheter shaft. Additionally, one embodiment of the handle member has internal grooves on the outer wall of the handle member, so that the user would have finger placement holds. The handle member may be made of a softer material than the catheter shaft, and have a tapered outer surface for comfort of the user.

BACKGROUND OF THE INVENTION

[0001] This invention generally relates to intravascular catheters, suchas balloon catheters used in percutaneous transluminal coronaryangioplasty (PTCA) and stent delivery.

[0002] PTCA is a widely used procedure for the treatment of coronaryheart disease. In this procedure, a balloon dilatation catheter isadvanced into the patient's coronary artery and the balloon on thecatheter is inflated within the stenotic region of the patient's arteryto open up the arterial passageway and thereby increase the blood flowthere through. To facilitate the advancement of the dilatation catheterinto the patient's coronary artery, a guiding catheter having apreshaped distal tip is first percutaneously introduced into thecardiovascular system of a patient by the Seldinger technique throughthe brachial or femoral arteries. The catheter is advanced until thepreshaped distal tip of the guiding catheter is disposed within theaorta adjacent the ostium of the desired coronary artery, and the distaltip of the guiding catheter is then maneuvered into the ostium. Aballoon dilatation catheter may then be advanced through the guidingcatheter into the patient's coronary artery over a guidewire until theballoon on the catheter is disposed within the stenotic region of thepatient's artery.

[0003] The balloon is inflated to open up the arterial passageway andincrease the blood flow through the artery. Generally, the inflateddiameter of the balloon is approximately the same diameter as the nativediameter of the body lumen being dilated so as to complete thedilatation but not over expand the artery wall. After the balloon isfinally deflated, blood flow resumes through the dilated artery and thedilatation catheter can be removed therefrom.

[0004] In a large number of angioplasty procedures, there may be arestenosis, i.e. reformation of the arterial plaque. To reduce therestenosis rate and to strengthen the dilated area, physicians nowfrequently implant an intravascular prosthesis called a stent inside theartery at the site of the lesion. Stents may also be used to repairvessels having an intimal flap or dissection or to generally strengthena weakened section of a vessel. Stents are usually delivered to adesired location within a coronary artery in a contracted condition on aballoon of a catheter which is similar in many respects to a balloonangioplasty catheter, and expanded to a larger diameter by expansion ofthe balloon. The balloon is deflated to remove the catheter and thestent is left in place within the artery at the site of the dilatedlesion.

[0005] In both applications, the catheter must be advanced through thebody to the heart. Control and advancement of catheters is difficultbecause of their construction. The body of conventional catheters islong and tubular. The user must frequently manipulate, or torque, thecatheter shaft on the proximal end to facilitate advancement of thecatheter with a desired orientation on the distal end. To provide theneeded control over the movement of the catheter, it is necessary thatthese tubular catheters be made somewhat rigid. However, catheters mustbe flexible enough to navigate through the body lumen to arrive at thedesired location within the body where the medical procedures will beperformed. An overly rigid catheter shaft will not track, or follow, theguidewire. Therefore, reaching the desired location with the rigidcatheter is more difficult. In addition, the catheter shaft islubricious and smooth. A lubricious shaft is necessary to facilitateadvancement within the body lumen. A user may have difficulty creating asufficient grip on the catheter shaft.

[0006] Therefore, what has been needed is a device that improvestorquability of the catheter without interfering with the tracking andadvancing of the catheter. The present invention satisfies these andother needs.

SUMMARY OF THE INVENTION

[0007] The present invention is directed to a handle member for grippinga catheter shaft to facilitate advancement on a patient's body lumen.The handle member is configured to be releasably secured to the cathetershaft. Further, the handle is longitudinally displaceable along at leasta length of the catheter shaft, so as to be slidably positional alongthe shaft. The handle member is comprised of a proximal end, a distalend, at least one lumen extending therethrough, and a connecting member.

[0008] The proximal end and the distal end of the handle member eachhave ports. The ports are completely surrounded by the handle membermaterial. The catheter shaft passes through the proximal end port,advances through the lumen and passes through the distal end port. Thehandle member may be slidably positional on the catheter shaft. In suchan embodiment, the connecting member in the handle member can be engagedto connect with the catheter shaft upon reaching a desired position. Theconnecting member frictionally engages the catheter shaft. Theconnection allows the handle member to secure to the catheter shaft, sothe handle member will not move.

[0009] In one embodiment of the invention, the handle member is disposedabout a catheter shaft having an adapter attached to the proximal end ofthe catheter shaft. The handle member is disposed about the cathetershaft at a location distal to the adapter. In yet another embodiment,the handle member is detachably connected to the adapter.

[0010] The handle member may have a connecting member of any type thatwould adequately grip the catheter shaft. Such connecting membersinclude, but are not limited to clips, clamps, clasps, vises, locks andvalves. Specifically, a rotational hemostatic valve is an adequateconnecting member. A rotational hemostatic valve (“RHV”) generallyutilizes a three-piece assembly. First, the RHV has a sleeve. Theinterior of the sleeve had threads. For this invention, the sleeve maybe the distal end of the handle member. The RHV also has a cap thatextends partially within the sleeve. The cap has threads correspondingto the sleeve internal threads. The third piece is an O-ring, or othercompressible member. The cap will compress the compressible member whenit is turned within the sleeve. The compressible member then grips thecatheter shaft, anchoring the RHV.

[0011] An important aspect of this invention is not only the additionalcontrol it would grant the user, but the added comfort the user wouldexperience. This is especially true for long procedures. An embodimentof the invention has outer walls, and a taper between the proximal anddistal ends and the center of the handle member on the outer wall. Thisembodiment allows for more comfortable prolonged gripping. Anotherembodiment includes a deformation of the outer walls in such a way as toenhance user comfort. A specific embodiment defines internal grooves onthe outer wall of the handle member. A user may prefer to use suchinternal grooves as finger holds, allowing the user to have a securehold on the handle member without an uncomfortable grip. The user isthereby able to work with more control for a long period of time.

[0012] Additionally, the handle may be manufactured from a material thatis softer than the catheter shaft. Therefore, a wide variety of softpolymeric materials allow for a comfortable grip. Specifically, athermoplastic rubber such as Santoprene® thermoplastic rubber fromAdvanced Elastomer Systems, a soft and sticky material, is a successfulmaterial. Alternatively, a polycarbonate may form the push device toprovide support and strength, with a layer of Santoprene® added toprovide a better grip.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013]FIG. 1 is an elevational view of the catheter system embodyingfeatures of the invention, with a handle member attached to an adapter.

[0014]FIG. 2 is an elevational view of the proximal portion of thecatheter system of FIG. 1, with the handle member attached to anadapter.

[0015]FIG. 3 is a transverse cross sectional view of the catheter systemof FIG. 2 taken along the line 3-3.

[0016]FIG. 4 is a longitudinal cross sectional view of the cathetersystem of FIG. 2 taken along the line 4-4 with the connecting memberengaged.

[0017]FIG. 5 is a transverse cross sectional view of the catheter systemof FIG. 4 taken along the line 5-5.

[0018]FIG. 6 is a longitudinal cross sectional view of the cathetersystem of FIG. 2 taken along the line 44 with the connecting memberdisengaged.

[0019]FIG. 7 is a transverse cross sectional view of the catheter systemof FIG. 6 taken along the line 7-7.

DETAILED DESCRIPTION OF THE INVENTION

[0020] As shown in FIG. 1, the catheter 10 embodying features of theinvention generally includes a catheter shaft 11 having a proximal end12, a distal end 13, an adapter 14, and a handle member 22 slidablydisposed about and capable of being releasably secured to the cathetershaft 11 at a location distal to an adapter 14. In the embodiment shownin FIG. 1, the handle member 22 is detachably connected to the adapter14.

[0021] As shown in detail in FIGS. 2-7, the handle member 22 has aproximal end 23 and a distal end 24. The proximal end 23 has a proximalport 25 for receiving the catheter shaft 11. The distal end 24 has adistal port 26 for receiving the catheter shaft 11. The handle member 22has at least one lumen 27 between the proximal port 25 and the distalport 26, which receives the catheter shaft 11. The handle member 22 isabout 1 to about 2 inches long. The lumen 27 defines an inner diameter.The inner diameter of the lumen 27 is generally no less than about 0.040inches (1.016 millimeters).

[0022] The handle member 22 has an outer diameter. In one embodiment,the outer diameter is not constant. Specifically, the outer diameter islarger at the handle member proximal end 23 and distal end 24 than theouter diameter at any point between the proximal end 23 and distal end24. The outer diameter will range from about 0.5 inches (12.7millimeters) to about 2.0 inches (50.8 millimeters). In certainembodiments, the outer diameter tapers from a larger to a smallertransverse dimension from the proximal end 23 to the center 28 of thehandle member 22, and from a smaller to a larger transverse dimensionfrom the center 28 to the distal end 24.

[0023] The handle member preferably has a deformation on the outersurface to enhance comfort of the grip for the user. This deformationmay be a texture on the outer surface, for example a sandpaper texture(not shown). The deformation may also include a design in the outersurface to conform to the user's hand (not shown). The deformation mayalso be a specific removal of material from the outer surface to enhancefinger placement, such as a dimple or a slot (not shown). In oneembodiment of the invention illustrated in FIG. 3, the handle member 22may have internal grooves 37 in the sides. These grooves 37 will allowfor comfortable finger placement during long procedures and a generallymore ergonomic grip. Certain embodiments may have at least two internalgrooves 37. Another embodiment may have the internal grooves 37 shapedas ovals. Specifically, these internal grooves 37 are configured toreceive a physician's fingers. In such an embodiment, the circle createdbefore forming the internal grooves 37 defines the outer diameter. Theembodiment illustrated in FIG. 3 has four oval shaped grooves 37.However, any number of internal grooves would be adequate for thisinvention.

[0024] The handle member 22 has a connecting member 29 to connect thehandle member 22 to the catheter shaft 11. The connecting member 29 maybe, but is not limited to, any available clip, clamp, clasp, vise, lockor snap. Specifically, the system used in a rotational hemostatic valvewould be an adequate connecting member 29. In the embodiment shown inFIG. 4, the connecting member 29 consists of a cap 30 and a compressiblering 31 within a distal portion of the handle member lumen 27. In thatembodiment, the connecting member 29 frictionally engages the cathetershaft 11 when secured thereto.

[0025] The cap 30 has a lumen 32 for receiving the catheter shaft 11.Similarly, the compressible ring 31 has a lumen 38 for receiving thecatheter shaft 11. The cap 30 has a head 33 and a body 34. The body 34extends within the handle member lumen 27. The body 34 has externalthreads 35 at least partially along the body's 34 longitudinal axis. Thehandle member 22 has internal threads 36, which compliment the externalthreads 35 on the body 34, on the distal end of the lumen 27. For thepurposes of this patent, complimenting threads are threads that canreceive each other. When the physician turns the head 33, the externalthreads 35 follow the internal threads 36 and rotate, moving the cap 30toward the handle member proximal end 23.

[0026] The proximal movement will compress the compressible ring 31. Thecompressible ring 31 has a lumen 38, which disappears as thecompressible ring 31 contacts the catheter shaft 11. The further thephysician turns the head 33, the more proximal the body 34 will traveland the compressible ring 31 will compress to form a firm grip on thecatheter shaft 11. FIG. 5 shows the connecting member 29 engaged to gripthe catheter shaft 11. FIG. 6 shows the cap 30 open so the compressiblering 31 does not engage the catheter shaft 11. Compressible ring lumen38 is clearly visible in FIG. 7.

[0027] Referring back to the embodiment illustrated in FIG. 1, thecatheter 10 is an over-the-wire catheter. The catheter shaft 1 1 has anouter tubular member 17 and an inner tubular 16 disposed within theouter tubular member 17 and defining, with the outer tubular member 17,an annular inflation lumen 18. Inflation lumen 18 is in fluidcommunication with an inflatable balloon 15. Inflation fluid isintroduced into the inflation port 19 on the adapter 14, travels throughthe inflation lumen 18, and inflates the balloon 15. The inner tubularmember 16 has an inner lumen 21 extending therein, which is configuredto slidably receive a guidewire 20 suitable for advancement through apatient's coronary arteries. The distal extremity of the balloon 15 issealingly secured to the distal extremity of the inner tubular member16, and the proximal extremity of the balloon 15 is sealingly secured tothe distal extremity of the outer tubular member 17.

[0028] Although individual features of embodiments of the invention maybe shown in some of the drawings and not in others, those skilled in theart will recognize that individual features of one embodiment of theinvention can be combined with any or all the features of anotherembodiment.

What is claimed is:
 1. A handle member for gripping a catheter shaft tofacilitate advancement in a patient's body lumen comprising a bodyhaving a proximal end, a distal end, at least one lumen and a connectingmember, configured to be releasably secured to the catheter shaft andwhen released to be longitudinally displaceable along at least a lengthof the catheter shaft so as to be slidably positional along the shaft.2. The handle member of claim 1, wherein the connecting memberfrictionally engages the catheter shaft when secured thereto.
 3. Thehandle member of claim 1, wherein the connecting member is chosen from agroup consisting of clips, clamps, clasps, vises, locks, snaps, o-ringvalves and rotational hemostatic valves.
 4. The handle member of claim1, wherein the connecting member comprises a) a cap having a head and abody with threads, the body extending within the handle member lumen; b)threads on the handle member lumen complimentary to the threads on thecap body; and c) a compressible member within the handle member lumen.5. The handle member of claim 1, wherein the handle member lumen has aninner diameter of no less than 0.040 inches (1.016 millimeters).
 6. Thehandle member of claim 1, wherein the handle member has an outerdiameter of about 0.5 inches (12.7 millimeters) to about 2.0 inches(50.8 millimeters).
 7. The handle member of claim 6 wherein the body hasa center section, and the handle member outer diameter at the centersection is smaller than the outer diameter at the proximal end, and thehandle member outer diameter at the center section is smaller than theouter diameter at the distal end.
 8. The handle member of claim 7,having a proximal tapered portion between the center section and theproximal end and a distal tapered section between the center section andthe distal end.
 9. The handle member of claim 1 wherein the body has adeformation configured to enhanced a user's grip.
 10. The handle memberof claim 1 wherein the body has an outer wall with internal grooves. 11.The handle member of claim 10 wherein the grooves are configured in theshape of at least 2 ovals.
 12. The handle member of claim 11 wherein theoval shapes are configured to receive a user's fingers.
 13. The handlemember of claim 1, wherein the handle member lumen has an inner diameterof no less than 0.040 inches (1.016 millimeters).
 14. The handle memberof claim 1, wherein the handle member has an outer diameter of about 0.5inches (12.7 millimeters) to about 2.0 inches (50.8 millimeters). 15.The catheter assembly of claim 14 wherein the handle member has a centersection, and the handle member outer diameter at the center section issmaller than the outer diameter at the proximal end.
 16. The catheterassembly of claim 15, having a proximal tapered portion between thecenter section and the proximal end and a distal tapered section betweenthe center section and the distal end.
 17. A catheter assemblycomprising a) a catheter shaft having a proximal end, a distal end andat least one lumen; and b) A handle member for gripping a catheter shaftto facilitate advancement in a patient's body lumen comprising a bodyhaving a proximal end, a distal end, at least one lumen and a connectingmember, configured to be releasably secured to the catheter shaft andwhen released to be longitudinally displaceable along at least a lengthof the catheter shaft so as to be slidably positional along the shaft.18. The handle member of claim 17, wherein the connecting memberfrictionally engages the catheter shaft when secured thereto.
 19. Thecatheter assembly of claim 17 wherein the handle member is a softermaterial than the catheter shaft.
 20. The catheter assembly of claim 17,further comprising an adapter attached to the catheter shaft proximal tothe handle member.
 21. The handle member of claim 17 wherein the bodyhas a deformation configured to enhanced a user's grip.
 22. The catheterassembly of claim 17 wherein the body has an outer wall with internalgrooves.
 23. The catheter assembly of claim 22 wherein the grooves areconfigured in the shape of at least 2 ovals.
 24. The catheter assemblyof claim 23 wherein the oval shapes are configured to receive a user'sfingers.
 25. A catheter assembly comprising a) a catheter shaft having aproximal end, a distal end and at least one lumen; b) an adapterattached to the proximal end of the catheter shaft; and c) a handlemember for gripping a catheter shaft comprising a body having a proximalend, a distal end, at least one lumen and a connecting member,configured to be releasably secured to the catheter shaft and whenreleased to be longitudinally displaceable along at least a length ofthe catheter shaft so as to be slidably positional along the shaft. 26.The catheter assembly of claim 25 wherein the adapter has threads on adistal portion, and the handle member has complimentary threads on thehandle member proximal end.